Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
Temporary Reimbursement Granted for Pediatric Smectite After Indication Removal
Korean Pharmaceutical Association secured a three‑day temporary reimbursement for di‑octahedral smectite dispensed to patients under 19, easing pharmacy billing concerns after pediatric indication was withdrawn.
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Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
MFDS reviews removal of pediatric indication for dioctahedralsmektate antidiarrheal
South Korea’s MFDS is considering deleting the pediatric indication for the dioctahedralsmektate antidiarrheal after safety data were deemed insufficient, following proactive applications by manufacturers.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Korea to ban dioctahedral smectite antidiarrheal from July 13
South Korea's MFDS will prohibit pediatric prescriptions of dioctahedral smectite after finding insufficient safety data on lead content, sparking recall concerns.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
South Korea bans pediatric use of Daewoong's Starvic and Daewon's Potagel suspensions
Daewoong’s Starvic and Daewon’s Potagel pediatric diarrhea suspensions are prohibited nationwide in Korea effective July 6, after MFDS found insufficient safety data for children.
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
PMDA Issues Early Guidance on Clinical Evaluation of Factor VIII & IX for Pediatric Hemophilia
The Pharmaceuticals and Medical Devices Agency released early considerations for evaluating blood coagulation factor VIII and IX products in children with congenital hemophilia.
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